Characterizing Expanded Access and Compassionate Use Programs for Experimental Drugs

Most (76%) provided drugs in expanded access programs eventually received FDA approval. Thus, provided drugs in registered expanded access programs are, more times than not, eventually deemed safe by the FDA.

How Full Disclosure of Clinical Trial Data will Benefit the Pharmaceutical Industry

Trial disclosures for new drugs remain below legal and ethics standards, with wide variation in practices among drugs and their sponsors. Best practices are emerging. 2 of our 10 reviewed companies disclosed all trials and complied with legal disclosure requirements for their 2012 approved drugs. Ranking new drugs on transparency criteria may improve compliance with legal and ethics standards and the quality of medical knowledge

The intent of the first national clinical trials registry for cancer therapies was to help doctors find open trials in which to enroll their patients and to help researchers maintain a steady supply of research participants. However, it ended up exposing corrupt practices and tensions between ethics, the corporate need for profits, and public health goals. How did this happen?

After years of decline in the public eye, drug companies should implement a bioethics accreditation or rating program to help appropriately restore the industry’s good name and improve its effectiveness in advancing global health and new treatments.

Miller, J. E. (2013). From Bad Pharma to Good Pharma: Aligning Market Forces with Good and Trustworthy Practices through Accreditation, Certification and Rating. Journal of Law, Medicine, and Ethics, 41 (3), 601-610.

This article explores whether the bioethical performance and trustworthin ess of pharmaceutical companies can be improved by harnessing market forces through the use of accreditation, certification, or rating.

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Why Is Transparency Important?

Commitment to quality patient care includes a deep concern for the ethical aspects of medicine... an institution dedicated to excellence in health care must have the benefit of bioethics services.